KEI request to BARDA concerning Moderna obligations to disclose federal funding in patent applications

On September 2, 2020, Knowledge Ecology International (KEI) sent a letter to the Biomedical Advanced Research and Development Authority (BARDA) regarding a potential failure by Moderna, Inc. to disclose federal funding in patents supported by BARDA. KEI requested information concerning… Continue Reading

WHO Director-General Remarks in support of global pooling of rights in COVID-19 Technologies and data, in open science and open data

On April 6, 2020, the Director-General of the World Health Organization (WHO), Dr. Tedros Ghebreyesus, gave a media briefing on COVID-19 and the WHO’s efforts to combat the pandemic. In his remarks, Dr. Tedros specifically highlighted the proposal by the… Continue Reading

Open letter to the World Health Organization (WHO) and its Member States on the proposal by Costa Rica to create a global pool for rights in the data, knowledge and technologies useful in the prevention, detection and treatment of the coronavirus/COVID-19 pandemic

March 27, 2020. We are writing to ask the WHO and its Member States to support the proposal by Costa Rica for the creation of a global pooling mechanism for rights in the data, knowledge and technologies useful in the… Continue Reading

FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’

On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation from the US Food and Drug Administration (FDA) for the treatment of COVID-19. Remdesivir has been reported to be one of the candidates to potentially treat COVID-19, which the… Continue Reading

House Coronavirus Bill Provision Could be Used for COVID-19/Coronavirus-Related R&D without Public-Interest Safeguards

A House coronavirus stimulus bill contains a provision concerning the use of Other Transactions Authority to fund COVID-19 diagnostics. The provision appears to authorize the Department of Homeland Security (DHS) to award $2.2 billion to private sector companies to develop… Continue Reading

FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease

Today the FDA granted Gilead Orphan Drug status for remdesivir for the treatment of COVID-19, on grounds this is a rare disease. The morning of the designation, the U.S. had confirmed, through testing, more than 35 thousand cases, including 8,477… Continue Reading